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Comparison of Cariostatic Effect of Nano-Silver Fluoride Versus Silver Diamine Fluoride

Primary Purpose

Dental Caries in Children

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Nano-Silver Fluoride
Silver diamine fluoride
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries in Children

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Children aged from 3 to 5 years clinical diagnosis of active dentinal caries in primary teeth Co-operative participants and free of any systemic diseases Exclusion Criteria: Children whose parents refuse to sign consent Primary teeth with pulp involvement, pain, mobility, abscess, sinus, fistula; or discoloration related to tooth non-vitality.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Silver Diamine Fluoride

    Nano-Silver Fluoride

    Arm Description

    38% Silver Diamine Fluoride varnish the affected tooth will be cleaned by a disposable micro-brush for 30 seconds and then will be dried using cotton gauze sponges. No excavation will be done to the infected dentin tissue prior to the application of the agent. Gum will be protected with petroleum jelly, and isolation will be achieved by using cotton rolls. After isolation, a single drop SDF will be applied into the cavity by using a disposable micro-brush for at least two minutes. Then site of application will be covered with petroleum jelly. Finally, parents will be instructed that children participating in the trial are not allowed to eat or drink for one hour after application of the agent

    Nano-Silver fluoride varnish preparation the affected tooth will be cleaned by a disposable micro-brush for 30 seconds and then will be dried using cotton gauze sponges. No excavation will be done to the infected dentin tissue prior to the application of the agent. Gum will be protected with petroleum jelly, and isolation will be achieved by using cotton rolls. After isolation, a single drop NSF will be applied into the cavity by using a disposable micro-brush for at least two minutes. Then site of application will be covered with petroleum jelly. Finally, parents will be instructed that children participating in the trial are not allowed to eat or drink for one hour after application of the agent

    Outcomes

    Primary Outcome Measures

    caries lesion activity and severity assessment using Nyvad criteria
    visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling )
    caries lesion activity and severity assessment using Nyvad criteria
    visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling )
    caries lesion activity and severity assessment using Nyvad criteria
    visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling )

    Secondary Outcome Measures

    ICDAS II
    Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin )
    ICDAS II
    Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin )
    ICDAS II
    Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin )

    Full Information

    First Posted
    June 21, 2023
    Last Updated
    July 10, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05941429
    Brief Title
    Comparison of Cariostatic Effect of Nano-Silver Fluoride Versus Silver Diamine Fluoride
    Official Title
    Comparison of Cariostatic Effect of Nano-Silver Fluoride Versus Silver Diamine Fluoride in a Group of Preschool Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    This study will be conducted to test the cariostatic effect of Nano Silver Fluoride in a comparison to Silver Diamine Fluoride in a group of preschool children.
    Detailed Description
    Silver Diamine Fluoride has offered a non-invasive and easily performed method to manage dental caries in very young children.Studies shows that SDF has been proven to arrest caries in cavitated lesions and to prevent caries in sound teeth as Fluoride is effective in enhancing the remineralization of dental hard tissue and silver ion acts as an antibacterial agent. However, It was found that silver causes staining to the dental tissues with a black discoloration, which can be considered to be a main drawback specifically, when it is used on anterior teeth. Nano-silver fluoride varnish preparation showed high efficacy in arresting caries progression in primary teeth without causing black discoloration to the tissues.Silver diamine fluoride (SDF) . Benefits for patient: Non-invasive treatment leading to reduce patient anxiety and stress. No drilling and filling. Protects against further caries progression. Benefits for the practitioner: Provide alternative treatment options. Pain-free procedure that facilitates child management and saves time. Benefits for the community: Increasing overall oral health Provides more information by testing new material To provide better service quality.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries in Children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Double blinded study. Participants were blinded towards agents used in the study by using two identical squeezable plastic droppers with tag codes A and B. Also the bio-statistician will be blinded from the meaning of codes.
    Allocation
    Randomized
    Enrollment
    78 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Silver Diamine Fluoride
    Arm Type
    Active Comparator
    Arm Description
    38% Silver Diamine Fluoride varnish the affected tooth will be cleaned by a disposable micro-brush for 30 seconds and then will be dried using cotton gauze sponges. No excavation will be done to the infected dentin tissue prior to the application of the agent. Gum will be protected with petroleum jelly, and isolation will be achieved by using cotton rolls. After isolation, a single drop SDF will be applied into the cavity by using a disposable micro-brush for at least two minutes. Then site of application will be covered with petroleum jelly. Finally, parents will be instructed that children participating in the trial are not allowed to eat or drink for one hour after application of the agent
    Arm Title
    Nano-Silver Fluoride
    Arm Type
    Experimental
    Arm Description
    Nano-Silver fluoride varnish preparation the affected tooth will be cleaned by a disposable micro-brush for 30 seconds and then will be dried using cotton gauze sponges. No excavation will be done to the infected dentin tissue prior to the application of the agent. Gum will be protected with petroleum jelly, and isolation will be achieved by using cotton rolls. After isolation, a single drop NSF will be applied into the cavity by using a disposable micro-brush for at least two minutes. Then site of application will be covered with petroleum jelly. Finally, parents will be instructed that children participating in the trial are not allowed to eat or drink for one hour after application of the agent
    Intervention Type
    Drug
    Intervention Name(s)
    Nano-Silver Fluoride
    Other Intervention Name(s)
    NSF
    Intervention Description
    NSF is a varnish which has been introduced as experimental formulation . the laboratory synthesis of NSF was carried out in a nano techonolgy center .
    Intervention Type
    Drug
    Intervention Name(s)
    Silver diamine fluoride
    Other Intervention Name(s)
    SDF
    Intervention Description
    38% silver diamine fluoride
    Primary Outcome Measure Information:
    Title
    caries lesion activity and severity assessment using Nyvad criteria
    Description
    visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling )
    Time Frame
    baseline
    Title
    caries lesion activity and severity assessment using Nyvad criteria
    Description
    visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling )
    Time Frame
    3 weeks
    Title
    caries lesion activity and severity assessment using Nyvad criteria
    Description
    visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling )
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    ICDAS II
    Description
    Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin )
    Time Frame
    baseline
    Title
    ICDAS II
    Description
    Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin )
    Time Frame
    3 weeks
    Title
    ICDAS II
    Description
    Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin )
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Children aged from 3 to 5 years clinical diagnosis of active dentinal caries in primary teeth Co-operative participants and free of any systemic diseases Exclusion Criteria: Children whose parents refuse to sign consent Primary teeth with pulp involvement, pain, mobility, abscess, sinus, fistula; or discoloration related to tooth non-vitality.

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Cariostatic Effect of Nano-Silver Fluoride Versus Silver Diamine Fluoride

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